Label: QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH- camphor, menthol, methyl salicylate cream

  • NDC Code(s): 63868-692-04
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 25, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredient

    Camphor 4%

    Menthol 10%

    Methyl salicylate 30%

  • Purpose

    Camphor - Topical analgesic

    Menthol - Topical analgesic

    Methyl salicylate - Topical analgesic

  • Uses

    temporarily relieves minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
  • Warnings

    For external use only

    Do not Use

    • on wounds or damaged skin
    • with a healing pad
    • on a child under 12 years of age with arthritis-like conditions

    Ask a doctor before use if you have

    redness over the affected area

    When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

    • skin redness or excessive irritation of the skin occurs
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • adults and children 12 years and over; apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age; consult a physician
  • Other Information

    • Store at 20-25 C (68-77F)
    • do not use if tube seal under cap is broken
  • Inactive Ingredients

    carbomer homopolymer type c, cetostearyl alcohol, cetyl alcohol, glyceryl monostearate, methylparaben, peg-100 stearate, polysorbate 60, propylparaben, stearic acid, trolamine, water

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM  ULTRA STRENGTH
    camphor, menthol, methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-692
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)40 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-692-041 in 1 CARTON03/01/2021
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/01/2021
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANICARE PHARMACEUTICALS PRIVATE LIMITED916837425manufacture(63868-692)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!